Qualilab

What Qualilab does

Qualilab SAS is a French consulting and training firm founded in 1989 in Orléans, currently headquartered in Olivet (south of Orléans) with additional regional presence in the Paris and Nantes areas. The firm specializes in quality management, regulatory affairs and toxicology, qualification and validation of information systems and analytical methods, and statistical data analysis for clients in highly regulated industries. Its primary verticals are the pharmaceutical industry, accredited laboratories, healthcare/medical biology, the cosmetics industry, the chemical/phytosanitary sector, and biotechnology/medical devices, serving R&D labs, production sites, subcontractors, and government entities (including French hospitals via CAIH framework agreements).

Qualilab's core technology offering includes four SaaS statistical software products (e.noval, Stab.e.lity, Transval, Seelva) distributed under partnership with Pharmalex, which apply the accuracy profile methodology based on total error to physicochemical method validation, stability studies, method transfer, and immunoassay validation. The firm also owns the Qual.e.SI methodology, a 7-step continuous improvement framework for computerized system validation and data integrity in accredited laboratories. Revenue is generated through three streams: project-based consulting engagements, certified training (Qualiopi-certified training organization No. 24.45.04613.45), and annual SaaS subscriptions for its software portfolio. The company typically manages around 100 projects per year with an 11-50 person multidisciplinary team.

Following its departure from the Neovix-Biosciences group at the end of February 2025, Qualilab became part of the Biofortis Group, which maintains operations in Le Plessis-Robinson and Saint-Herblain, France. The firm is directed by Eric Chapuzet, a co-founder since 1989, and maintains active membership in industry associations including SOFAQ, GAMP Francophone, ISPE, A3P, SFSTP, and DMB, alongside university teaching engagements at Orléans and Tours.

Name

Qualilab

Legal name

Qualilab SAS

Website

https://qualilab.com

Company type

Private

Founded year

1989

Operating status

Operating

Headcount range

11–50 employees

Short description

Qualilab is a French consulting and training firm, founded in 1989 and now part of Biofortis Group, that provides quality management, regulatory affairs, computerized system validation, and statistical data analysis services to pharmaceutical, healthcare, cosmetic, and accredited laboratory clients across France and internationally.

Ownership category

akta.pro rank

Product category

Quality Management Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Computer Systems Design and Related Services (54151), Medical Laboratories (621511)

SIC

Services-Testing Laboratories (8734), Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071)

akta.pro primary industry

Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)

akta.pro secondary industries

Laboratory Quality & GLP/GCLP Compliance (HLAGAKAK), Compliance Technology, GRC Platforms & Controls Automation Advisory (BPAHAFAO), QA, Test Automation & Software Quality (Manual/Automated Testing, Performance) (EDABAFAL)

Keywords

• Quality management consulting
• Regulatory affairs services
• Analytical method validation
• Computerized system validation
• GxP compliance training

Headquarters

HQ city

Olivet

HQ country

France

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. Consulting Services: Quality management consulting, regulatory affairs and toxicology, qualification/validation services, information systems support, and analytical support. Provided as project-based engagements with expert consultants.
2. Training Services: Certified training organization (No. 24.45.04613.45) offering tailored training modules for quality management, information systems, regulatory affairs, analytical support, and data analysis. Training delivered on client premises, at Qualilab offices, or via videoconference.
3. Software Distribution: Markets and supports statistical software solutions (e.noval, Stab.e.lity, Transval, Seelva) offered as Software as a Service (SaaS) with annual subscriptions.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Qualilab is a French consulting and training firm that helps regulated organizations establish and maintain quality management systems, validate analytical methods and computerized systems, ensure data integrity, and comply with GxP, ISO, and FDA/ANSM regulatory requirements. The firm delivers project-based consulting across pharmaceutical, cosmetic, healthcare, biotechnology, chemical, and accredited laboratory sectors, complemented by a certified training organization and SaaS distribution of statistical validation software (e.noval, Stab.e.lity, Transval, Seelva).

Product overview

Qualilab offers a portfolio of four SaaS software products — e.noval, Stab.e.lity, Transval, and Seelva — distributed as Software as a Service solutions requiring only a web browser and internet access. These tools address the analytical method lifecycle: e.noval handles validation of physicochemical methods; Stab.e.lity manages stability studies and expiry criteria; Transval evaluates method transfers between laboratories; and Seelva validates immunoassay methods. All four follow the accuracy profile methodology based on total error and comply with ICH, FDA, ISO, and 21 CFR Part 11 where applicable. Complementing the software, Qualilab provides consulting services across Quality Management, Information Systems, Regulatory Affairs and Toxicology, Analytical Support, and Data Analysis, supported by a structured methodology (Qual.e.SI) for computerized systems management. A certified training organization, Qualilab also delivers tailored training courses in these domains, primarily serving pharmaceutical, cosmetic, medical device, chemical, and healthcare sectors across France.

Differentiator

Problem solved

Functional benefit

Products and services

• e.noval

Quantifiable outcome

• Each year, experts meet with more than 300 contacts and manage around one hundred projects
• +1 more outcomes

Named customers4 records

Segments6 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Four partnerships are on record, tiered minor and core.

• LFB (LFB S.A.)minorStrategic or Co-development Partner · 4 June 2025Co-hosted conference at Polepharma Biotesting 2025 congress on 'Analytics and Statistics - Key Challenges in Comparability Studies'. Collaborative industry engagement.
• PharmalexcoreTechnology or IntegrationPharmalex developed and validated software solutions (e.noval, Stab.e.lity, Transval, Seelva) that Qualilab markets and supports in France. These SaaS statistical software tools are dedicated to analytical method validation, stability studies, and method transfer evaluation.
• CAIH (Centrale d'Achat de l'Informatique Hospitalière)coreChannel Partner/ Reseller/ DistributorCAIH selected Qualilab as an approved vendor for computerized system validation services for French hospital centers. Contract established for 4 years covering metropolitan France and overseas departments for validation of computerized systems used in clinical research.
• White-TilletminorStrategic or Co-development PartnerCabinet White-Tillet, a regulatory affairs consultancy specializing in medical devices and health products, joined Neovix-Biosciences group in 2021. White-Tillet offers complementary services including technical file documentation, QMS implementation, and training via IFEP.

Scale indicators4 records

Recent moves9 records

Expansion highlights5 records

Direct peers

• Pharmalex: Developed the e.noval, Stab.e.lity, Transval, and Seelva SaaS suite that Qualilab distributes. Both serve pharma/regulatory affairs clients with software + consulting in analytical method validation — directly overlapping in product and customer base.
• White-Tillet: French regulatory affairs consultancy specializing in medical devices and health products; was a Neovix-Biosciences sister entity. Direct comparable in QMS implementation, technical file documentation, and training.
• Voisin Consulting Life Sciences (VCLS): Regulatory affairs and quality consulting firm serving pharma, biotech, and medical devices. Closely comparable in scope (regulatory, quality, toxicology) and client profile to Qualilab.

Broad incumbents

• Biofortis Group: Qualilab's parent group since Feb 2025, offering complementary services in regulatory affairs, toxicology, and quality across France. Operates in the same quality/regulatory niche with broader service portfolio.
• Eurofins Scientific: Global leader in testing/analytical services with deep pharma and medical-device exposure. Comparable as a quality/compliance support provider, though much larger and broader in scope.
• SGS Life Sciences: Provides quality, regulatory, and laboratory services to pharma and life sciences. Overlaps with Qualilab in regulatory affairs and quality management consulting, but at global scale.
• Bureau Veritas: Testing, inspection, and certification firm serving healthcare/life-sciences with quality and compliance offerings. Comparable in accreditation support and regulatory compliance services.
• Veeva Systems: Cloud software for life sciences including quality/regulatory and validation suites. Competes in adjacent software layer; both serve regulated-life-sciences compliance buyers.
• Capgemini Engineering (Altran): Large IT/digital services firm with life-sciences regulatory and validation consulting practices. Comparable in computer system validation and GxP services, though at far greater scale.

Emerging players

• MasterControl: Quality management / GxP software vendor competing in pharmaceutical QMS and computerized system validation — overlapping with Qualilab's Qual.e.SI methodology and consulting practice.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/qualilab
• Xx.com/qlb45160

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Qualilab